History of Research Ethics | Research Services | University of Missouri – Kansas City

prior to 1906, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no Food and Drug Administration ( FDA ), no Common Rule, and no Institutional Review Board ( IRB ). What follows is a brief discussion of why union rules and regulations were established and why the IRB became a necessity .

Nuremberg Code

A long-familiar chapter in the history of research with human subjects opened on December 9, 1946, when an american military court opened criminal proceedings against 23 leading german physicians and administrators for their volition participation in war crimes and crimes against humanity. Among the charges were that german physicians conducted aesculapian experiments on thousands of concentration camp prisoners without their accept. Most of the subjects of these experiments died or were permanently crippled as a resultant role .
As a address resultant role of the test, the Nuremberg Code was established in 1948, stating that “ The voluntary consent of the homo subject is absolutely substantive, ” making it clear that subjects should give consent and that the benefits of inquiry must outweigh the risks .
Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated volunteer engagement and informed consent.

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In the late 1950s, thalidomide was approved as a ataractic in Europe ; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused austere deformities in the fetus. many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give inform consent. Some 12,000 babies were born with dangerous deformities due to thalidomide .
U.S. Senate hearings followed and in 1962 the alleged “ Kefauver Amendments ” to the Food, Drug and Cosmetic Act were passed into law to ensure drug efficacy and greater drug condom. For the inaugural time, drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them .

Tuskegee Syphilis Study (1932-1972)

An equally well known chapter in history occurred during a inquiry stick out conducted by the U.S. Public Health Service. Six hundred low-income african-american males, 400 of whom were infected with syphilis, were monitored for 40 years. Free checkup examinations were given ; however, subjects were not told about their disease. even though a prove cure ( penicillin ) became available in the 1950s, the study continued until 1972 with participants being denied discussion. In some cases, when subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent discussion. many subjects died of syphilis during the study. The study was stopped in 1973 by the U.S. Department of Health, Education, and Welfare only after its universe was publicized and it became a political embarrassment. In 1997, under mounting blackmail, President Clinton apologized to the analyze subjects and their families.

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Declaration of Helsinki

In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international inquiry ethics and defines rules for “ research combined with clinical care ” and “ non-therapeutic research. ” The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today .
Issues addressed in the Declaration of Helsinki include :

  • Research with humans should be based on the results from laboratory and animal experimentation
  • Research protocols should be reviewed by an independent committee prior to initiation
  • Informed consent from research participants is necessary
  • Research should be conducted by medically/scientifically qualified individuals
  • Risks should not exceed benefits

National Research Act (1974)

due to the publicity from the Tuskegee Syphilis Study, the National Research Act of 1974 was passed. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was charged to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such inquiry is conducted in accord with those principles .
The Commission drafted the Belmont Report, a foundational document in for the ethics of human subjects research in the United States .
In Summary :

  • Nazi atrocities in World War II drew attention to the lack of international standards on research with human subjects and led to the formulation of the Nuremberg Code.
  • The thalidomide disaster led to the adoption of the “Kefauver Amendments” to the Food, Drug and Cosmetic Act, requiring drug manufacturers to prove to the FDA the effectiveness of their products before marketing them.
  • The Declaration of Helsinki is the basis for Good Clinical Practices used today.
  • The Tuskegee Syphilis Study is probably the worst case of unethical human subjects research in the history of the United States.
  • The National Research Act codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report.
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